|
Device | TALENT AND BRIO PACEMAKERS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S015 |
Date Received | 10/31/2001 |
Decision Date | 11/26/2001 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CHANGE THE SILICONE HEADER CURRENTLY IN USE WITH THE SINGLE CHAMBER TALENT AND BRIO DEVICES TO TECOTHANE 75D POLYURETHANE HEADER (RIGID HEADER). |